- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529821
Additional Effects of Pilates Breathing and Diaphragmatic Breathing Combined With Moderate Intensity Continuous Treadmill Training on Blood Pressure, Chest Expansion, Pulmonary Function and Quality Of Life in Pre-hypertensive Patients
Pre-hypertension is defined as systolic blood pressure between 120-139mmHg or diastolic blood pressure between 80-89mmHg and is considered a risk factor for developing hypertension. Early lifestyle interventions such as aerobic exercise and breathing techniques may help prevent progression to hypertension. This randomised controlled trial aims to determine the additional effects of pilates breathing and diaphragmatic breathing combined with moderate-intensity continuous treadmill training on blood pressure, chest expansion, pulmonary function and quality of life in pre-hypertensive patients.
A total of 45 participants will be randomly allocated into three groups:
treadmill training with pilates breathing, tredmill training with diaphragmtic brething and treadmill training alone. The intervention will be conducted for 6 weeks. Outcome measures including blood pressure, pulmonary function, chest expansion and quality of life will be assesed before and after the intervention.
Study Overview
Status
Conditions
Detailed Description
Pre-hypertension is defined as systolic blood pressure between 120-139mmHg or diastolic blood pressure between 80-89mmHg.
This study is a three-arm parallel randomized controlled trial designed to evaluate the additional effects of pilates breathing and diaphragmatic breathing combined with moderate-intensity continuous treadmill training (MICT) in individuals with prehypertension.
A total of 45 participants aged 20-55 years diagnosed with prehypertension will be recruited from the Rehabilitation OPD of Fauji Foundation Hospital Rawalpindi. Participants will be randomly allocated into three groups:
Group A (Pilates breathing + treadmill training), Group B (Diaphragmatic breathing + treadmill training), and Group C (Treadmill training only). The intervention will be performed three times per week for six weeks. Treadmill training will follow a moderate-intensity continuous training protocol based on 55-70% of maximum heart rate. Breathing exercises will be performed for 10-15 minutes per session. Data will be analyzed using SPSS software.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sana Bashir, PhD*
- Phone Number: +923218529475
- Email: drsana.bashir@fui.edu.pk
Study Contact Backup
- Name: Iqra Zahid, MSPT-CPT
- Phone Number: 03310174987
- Email: iqrazahid31801@gmail.com
Study Locations
-
-
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Islamabad, Pakistan
- Recruiting
- Foundation University Islamabad
-
Contact:
- Sana Bashir
- Phone Number: 03218529475
- Email: drsana.bashir@fui.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Prehypertensive individuals (SBP 120-139 mmHg or DBP 80-89 mmHg)
- Age 20-55 years
- Both male and female
- Sedentary individuals according to IPAQ
- Willing to participate and provide informed consent
Exclusion Criteria:
- Diagnosed hypertension (≥140/90 mmHg)
- Cardiopulmonary diseases (COPD, asthma, CAD, heart failure)
- Musculoskeletal conditions preventing exercise
- Neurological disorders
- Pregnancy
- Participation in structured exercise in last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill training with Pilates breathing
Participants will perform moderate-intensity continuous treadmill training combined with pilates breathing exercises three times per week for six weeks.
|
Controlled lateral breathing technique focusing on rib cage expansion and core activation performed for 10-15 minutes, with low intensity, the perceived effort should be 3-4/10, with 3 days/week. A 06 weeks protocol will be followed. Steps: Patient in neutral spine position and hands placed on rib cage and abdomen. Inhale deeply expanding the ribs laterally. Exhale drawing the navel inward to engage core muscles. |
|
Experimental: Treadmill training with diaphragmatic breathing
Participants will perform moderate-intensity continuous treadmill training combined with diaphragmatic breathing exercises three times per week for six weeks.
|
Slow deep breathing emphasizing diaphragmatic movement performed for 10-15 minutes, with low intensity, the perceived effort should be 3-4/10, with 3 days/week. A 06 weeks protocol will be followed. Steps: Patient in supine or in seated position. Place one hand on chest and one below the ribs. Inhale slowly through the nose expanding the abdomen. Exhale through pursed lips, allowing the abdomen to fall inward and chest should remain still. |
|
Active Comparator: Treadmill training
Participants will perform moderate-intensity continuous treadmill training only, three times per week for six weeks.
|
70% of maximum heart rate for 20-35 minutes, three sessions per week for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure (SBP and DBP)
Time Frame: 06 weeks
|
Evaluation will be performed using an sphygmomanometer. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) will be recorded in millimeters of mercury (mmHg) under standardized conditions after adequate rest in a seated position. Blood pressure values will be recorded as continuous variables. Higher values indicate worse cardiovascular status, while lower values indicate improvement in blood pressure control. |
06 weeks
|
|
Chest Expansion
Time Frame: 06 weeks
|
Evaluation will be performed by measuring chest expansion using a measuring tape at three anatomical levels: axillary, nipple, and xiphoid. Measurements will be taken as the difference (in centimeters, cm) between maximum chest circumference at full inspiration and at full expiration at each level. Higher values indicate greater chest wall mobility and improved respiratory function, whereas lower values indicate restricted chest expansion. |
06 weeks
|
|
Pulmonary Function Test
Time Frame: 06 weeks
|
Evaluation will be performed using a spirometer machine in accordance with standard guidelines. The parameters assessed will include Forced Expiratory Volume in 1 second (FEV₁), Forced Vital Capacity (FVC), and FEV₁/FVC ratio. Values will be recorded in liters (L) and as percentage of predicted values (%) based on age, sex, height, and ethnicity. Higher values of FEV₁ and FVC indicate better pulmonary function, while a higher FEV₁/FVC ratio indicates reduced airway obstruction and improved respiratory status. |
06 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUCP/CTR/2026/02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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